Principal Clinical Data Manager - Medical Devices & Diagnostics

<p><b>Principal Clinical Data Manager –Medical Devices & Diagnostics</b></p><p><b><u>Description</u></b></p><p></p><ul><li><p>You will be permanently employed by <span>Labcorp Drug Development </span>working in our Medical Devices & Diagnostics division working across multiple Sponsors.  </p></li><li><p>Office based or home based anywhere within the defined locations.</p></li><li><p>You must have previous experience of working in a lead clinical data management role within Medical Devices & Diagnostics.</p></li><li><p>Candidates must be fluent in English language (both verbal and written).</p></li></ul><p></p><p>Are you an experienced Senior Clinical Data Manager and looking for a new challenge? Join our growing team and discover your extraordinary potential by working as a <span>Principal </span>Clinical Data Manager within our Global Clinical Development department.</p><p>This is a great opportunity for a Senior Clinical Data Manager who wants to advance their Data Management career, working closely with the Manager of the team and leading a number global diagnostic studies. You will be responsible for the operational oversight of the Data Managers, Data Reviewers & other team members within the team/study.  </p><p></p><p>As Principal Clinical Data Manager, you will also work alongside the leadership team to provide guidance, mentoring and training to Data Managers and other team members. Initially you will lead 2 global cardiac diagnostic studies and take responsibility for the <span>development of project documentation, system set up, data entry & validation.</span></p><p></p><p><span>You will be a key member of the DM team, </span><span>joining bid defenses, capabilities presentations and other client engagements regarding budget, scope or DM processes.</span></p><p></p><p>Other duties will include:</p><ul><li><p>Lead multiple global Medical Devices & Diagnostics studies, work alongside Sponsors Database Build team and review any specifications related to the Database design.</p></li><li><p>Be accountable for all DM deliverables, as assigned per timeline, providing instruction to their DM study team and reviewing completed work.</p></li><li><p>Ensure all projects are completed according to relevant protocols, SOPs and GCP standards.</p></li><li><p>Work with Project Managers to build timelines to meet contracted milestones via communication with other Data Managers and during study initiation meetings.</p></li><li><p>DM project leadership and accountability, lead DM internal meetings, meet frequently with study leads of EDC Design, SAS Programming, Stats & PK to ensure all deliverables are planned and coordinated.</p></li><li><p>Identify risks/mitigations, effectively communicates to ensure database lock dates are achieved.</p></li><li><p>Develop and maintain client relationships, drive process improvements and team training.</p></li><li><p>Support Managers with regards to performance evaluation of other team members, aid their career development.</p></li><li><p>Support budget development process for DM opportunities.</p></li></ul><p></p><p><b>Education </b></p><ul><li><p>University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).</p></li><li><p>Additional relevant work experience will be considered in lieu of formal qualifications.</p></li></ul><p></p><p><b>Experience </b></p><ul><li><p>Have Lead DM experience, with exposure in medical devices & diagnostics.</p></li><li><p>EDC experience to include Medrio or IBM Clinical Development or Mednet would be advantageous.</p></li><li><p><span>Good experience/knowledge surrounding Database build and be able to review specifications sent by Sponsor. </span></p></li><li><p>Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives to encourage team members to seek solutions.</p></li><li><p>In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.</p></li><li><p>Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</p></li></ul><p></p><p><b><u>Keywords:</u></b></p><p>Labcorp Drug Development, Covance by Labcorp, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data manager, clinical data management, Clinical Data Management, Principal Data Manager, Manager CDM, Diagnostics, Medical Devices, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, field-based, United Kingdom, UK, Great Britain, England, Maidenhead, Reading, Berkshire, Birmingham, Cambridge, Sheffield, Manchester, Alderley Edge, Scotland, Edinburgh, Wales, Swansea, Austria, Bulgaria, Czech Republic, Greece, Hungary, Lithuania, Poland, Romania, Russia, Slovakia,  Bloemfontein, Centurion, South Africa, <b><span>#LI-Remote, </span></b><span>Remote, EMEA</span></p><p></p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>